HyperuricemiaPhase 1NCT05168683
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
A Phase 1 study testing Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal and Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state in people with Hyperuricemia and Gout, run by Allena Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal and Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2022to 23 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18 and 30 kg/m², inclusive.
- Body weight ≥50 kg
- Voluntary written informed consent
- Good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results
Who cannot join
- Current or recurrent disease that could affect the study conduct or laboratory assessments
- History of current or relevant previous non-self-limiting gastrointestinal disorders
- Currently suffering from disease known to impact gastric emptying, e.g., migraine, Type 1 or Type 2 diabetes mellitus
- Untreated hypertension or has hypertension under treatment.
- Diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
- As a result of a physical examination or screening investigations, and available prior to dosing evaluations, the PMI or medically qualified designee/physician responsible considers the volunteer unfit for the study
- Any contradictions to the gamma scintigraphy procedure
- Measured body temperature >38°C at screening visit (COVID-19 risk reduction procedure)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary
Glasgow, Scotland, G4 0SF
About this study
Official title: A Phase 1, Single Centre, Two-Part, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Characterize the In Vivo Performance of ALLN-346 Enteric Coated Tablets
The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.
Read the detailed description
This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast release and a slower sustained release. Subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. Subjects will attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal.
Part Two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of Part One.
- Conditions
- Hyperuricemia, Gout
- Being tested
- Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal, Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light mealDrug
Also called Engineered urate oxidase radiolabelled
Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken
Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed stateDrug
Also called Engineered urate oxidase radiolabelled
Selected dosing of Part One treatments in fasted and/or fed states
| Study group | Role | What they receive |
|---|---|---|
| Part One | Experimental | Four Study Treatments will be dosed during Part One of the study with radiolabelled ALLN-346 tablets (in 12 subjects): Treatment A ALLN-346 enteric coated (EC) fast release tablet; Treatment B ALLN-346 fast release capsule; Treatment C ALLN-346 EC slow release tablet; Treatment D ALLN-346 slow release capsule. Subjects will be dosed in a lightly fed state. Receives: Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal |
| Part Two | Experimental | Following completion of Part One of the study, study treatment (one or both of those administered in Part One) and dosing requirements will be confirmed for dosing in Part Two, to be administered in fasted and/or fed states (in 12 subjects). Receives: Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scintigraphic images to detect transit time of radiolabel release
To assess the onset of disintegration/release with transit time for the radiolabelled study treatments in each ALLN-346 formulation
Measured: 12 hours
Secondary outcomes (1)
Incidence of Adverse Events
Number of subjects with treatment emergent adverse events
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start11 Jan 2022
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Subjects in each study Part participate in all treatment arms of that Part.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Responsible party
- Sponsor
- Investigators
- Christine Tosone, Study director, Allena Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168683
- Sponsor's protocol ID
- ALLN-346-103
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Centre, Two-Part, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Characterize the In Vivo Performance of ALLN-346 Enteric Coated Tablets
- ClinicalTrials.gov ID
- NCT05168683
- Acronym / sponsor ID
- ALLN-346-103
- Conditions
- Hyperuricemia, Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- BDD Pharma Ltd
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.
Detailed description
This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast release and a slower sustained release. Subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. Subjects will attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal.
Part Two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of Part One.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects in each study Part participate in all treatment arms of that Part.
| Arm | Type | Receives |
|---|---|---|
| Part One | Experimental | Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light mealFour Study Treatments will be dosed during Part One of the study with radiolabelled ALLN-346 tablets (in 12 subjects): Treatment A ALLN-346 enteric coated (EC) fast release tablet; Treatment B ALLN-346 fast release capsule; Treatment C ALLN-346 EC slow release tablet; Treatment D ALLN-346 slow release capsule. Subjects will be dosed in a lightly fed state. |
| Part Two | Experimental | Drug: Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed stateFollowing completion of Part One of the study, study treatment (one or both of those administered in Part One) and dosing requirements will be confirmed for dosing in Part Two, to be administered in fasted and/or fed states (in 12 subjects). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 18 and 30 kg/m², inclusive.
- Body weight ≥50 kg
- Voluntary written informed consent
- Good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results
Key exclusion criteria (8 listed)
- Current or recurrent disease that could affect the study conduct or laboratory assessments
- History of current or relevant previous non-self-limiting gastrointestinal disorders
- Currently suffering from disease known to impact gastric emptying, e.g., migraine, Type 1 or Type 2 diabetes mellitus
- Untreated hypertension or has hypertension under treatment.
- Diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light mealAlso: Engineered urate oxidase radiolabelledDosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken | Drug | Part One |
| Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed stateAlso: Engineered urate oxidase radiolabelledSelected dosing of Part One treatments in fasted and/or fed states | Drug | Part Two |
Primary outcome
Scintigraphic images to detect transit time of radiolabel release
Time frame: 12 hours
To assess the onset of disintegration/release with transit time for the radiolabelled study treatments in each ALLN-346 formulation
1 secondary outcome
Incidence of Adverse Events
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Tosone study director
Allena Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal and Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state in people with Hyperuricemia and Gout, run by Allena Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scintigraphic images to detect transit time of radiolabel release (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.